Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
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Purpose
Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.
Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.
The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.
| Condition | Intervention |
|---|---|
| Dental Pain | Procedure: Dental anesthesia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
| Official Title: | Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block |
- To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. [ Time Frame: 2 years ]
| Enrollment: | 37 |
| Study Start Date: | October 2009 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Quicksleeper intraosseous anesthesia
Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.
|
Procedure: Dental anesthesia
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
|
|
Active Comparator: Inferior alveolar nerve block
Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.
|
Procedure: Dental anesthesia
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
|
Detailed Description:
Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection. Failure rate of local anesthesia highly increases with irreversible pulpitis or inflamed periradicular tissue.
Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia (from teeth 35 up to 38 and from 45 up to 48).
The primary aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.
Four clinical situations are evaluated : pulpitis; periapical abcess; pulpal hyperemia; asymptomatic decayed tooth.
Evaluated parameters are : speed of sedation, ability of cure, additional anesthesia needed, total of needles and cartridges used, side effects. Time and validation of complete anesthesia is controlled by pulp tester.
Studied population is patients cared in restorative, endodontics department.
Pulpal and periapical molar and premolar sedation is randomly managed by inferior alveolar nerve block or Quicksleeper intraosseous anesthesia, among studied population (divided in 2 groups of 50 patients). Pulp-tester measures anesthesia minute by minute.
The comparison of study results to bibliography, guidelines and advantages for using mechanical Quicksleeper anesthesia system will be discussed.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Irreversible pulpitis on second mandibular premolar or mandibular molars
- Necessity of pulpotomy or pulpectomy
Exclusion Criteria:
- Pregnancy, chest feeding
- Non dental emergency state
- hypersensibility to local anesthesia
- Pheochromocytoma
- Irregularity of cardiac rhythm
- Myocardial infarct in the 6 previous months
- Hepatic porphyria
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177423
| France | |
| Assistance Publique - Hôpitaux de Marseille | |
| Marseille, France | |
| Principal Investigator: | Herve TASSERY | Assistance Publique-Hôpitaux de Marseille |
More Information
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT01177423 History of Changes |
| Other Study ID Numbers: |
2009-08 2009-A00684-53 |
| First Submitted: | October 15, 2009 |
| First Posted: | August 9, 2010 |
| Last Update Posted: | August 29, 2014 |
| Last Verified: | August 2014 |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
restorative odontology Patients cared in restorative odontology department |
Additional relevant MeSH terms:
|
Toothache Tooth Diseases Stomatognathic Diseases Facial Pain Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |